Improving Psychological Wellbeing by Stress Reduction Among Parents Having Children With Neurodevelopmental Disorders

NCT06166550 | Active Not Recruiting DMC

• 1 other identifier: BSMMU/2022/10733
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

This project addresses the mental health challenges faced by parents caring for children with Neurodevelopmental Disorders (NDDs) in Bangladesh. These parents often experience high levels of stress, anxiety, and depression, impacting family dynamics and the child's development. The project aims to design, implement, and assess an intervention to reduce parenting stress and enhance parental well-being. This intervention focuses on emotional intelligence and will be delivered through in-person training and a mobile app. The study will use a cluster randomized controlled trial methodology, targeting parents of children diagnosed with NDDs. The study will be conducted in Child Development Centers in public medical college hospitals across Bangladesh. It will assess changes in parental stress, mental well-being, and emotional intelligence. Data collection will occur from January 2024 to June 2025. The project aims to recruit 480 parents from eight Child Development Centers, ensuring ethical considerations, data integrity, and participant privacy. The findings will be shared through national dissemination seminars, policy briefs, reports, and journal publications.

Conditions

Mental Health Issue

Keywords

Psychological wellbeing; Neurodevelopmental Disorder; Parental Stress; Emotional Intelligence

Outcome Measures

Primary Outcomes (3)

• Psychological well-being

  Psychological well-being: The WHO-5 Well-Being Index will assess participants' subjective well-being before and after the intervention. Raw scores range from 0 to 25, with higher scores indicating better well-being.

  12 weeks after completion of the intervention

• Parenting stress

  Parenting stress will be assessed by Parental Stress Scale, a 18-item Likert scale. Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.

  12 weeks after completion of two-day intervention

• Mental Health

  Mental health will be assessed using Depression, Anxiety, and Stress scale (DASS-9), a validated screening tool measuring depression, anxiety, and stress. Raw score ranges from 0 to 27, with higher score indicating more depression, anxiety, and stress.

  12 weeks after the intervention.

Secondary Outcomes (5)

• Emotional intelligence

  12 weeks after completion of the intervention

• Parenting Self-Efficacy

  12 weeks after completion of two-day intervention

• Parenting satisfaction

  12 weeks after the completion of the intervention

• Marital satisfaction

  12 weeks after the intervention

• Fidelity

  Perioperative.

Study Arms (2)

Intervention

EXPERIMENTAL

Parents of children suffering from neurodevelopmental disorders will be the participants. They will get in-person training on emotional intelligence and access to a mobile app and a personal diary aimed at enhancing their psychological wellbeing.

Behavioral: Parent's Emotional Intelligence Network; Device: Mobile App; Device: Diary

Control

NO INTERVENTION

This group will be in wait-list, get no intervention at the initial phase. They will get the intervention after the intervention period and the endline survey is over.

Interventions

Parent's Emotional Intelligence Network BEHAVIORAL

A two-day in-person training session will be arranged for the participating parents at least one week apart. The psychologists will conduct the training session on emotional intelligence. A training of the trainer manual will be developed to train the psychologists. The training session will include a power point presentation and certain group and individual activities to practice emotional intelligence. The participants will also be given a diary and a mobile app in order to practice emotional intelligence at home.

Intervention

Mobile App DEVICE

A mobile app (MonKotha) has been developed along with user manual. It contains different videos, audios, and texts related to emotional intelligence. It also provides a communication platform where users can communicate through texts and upload documents.

Also known as: MonKotha - A parents' emotional intelligence network

Intervention

Diary DEVICE

A diary (Onuvutir Diary) is also developed that contain different practice materials regarding emotional intelligence. It is a personal diary given to the participants to take to home.

Also known as: Onuvutir Diary

Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Parents of any age having children with neurodevelopmental disorders i.e. Autism Spectrum Disorders, Cerebral Palsy, Intellectual disorders, attention deficit hyperactivity disorders, and Down Syndrome.
• Parents of children whose diagnosis were made within one year (to avoid the time-effect on stress and mental health).
• Parents' age limit will be 18-50 years

You may not qualify if:

• Parents having children with serious sensory impairments (e.g., deafness and blindness) and oxygen dependence due to chronic lung diseases.
• Parents who need pharmacological management at initial assessment.

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead
• Centre for Injury Prevention and Research Bangladesh: collaborator
• University of Dhaka, Bangladesh: collaborator
• Directorate General of Health Services, Ministry of Health and Family Welfare, Bangladesh: collaborator

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

Location

Related Publications (1)

• Salwa M, Chowdhury SM, Rois R, Uddin MK, Akhter S, Nahar K, Mullick AR, Mannan M, Kundu GK, Fatema K, Maruf Haque Khan M, Haque MA. Leveraging emotional intelligence to alleviate mental health: protocol of a cluster randomised controlled trial among parents of children with neurodevelopmental disorders in Bangladesh. BMJ Open. 2025 Sep 30;15(9):e105688. doi: 10.1136/bmjopen-2025-105688.

  PMID: 41027705 DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders

Interventions

Medical Records

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Salim M Chowdhuri, PhD

  Center for Injury Prevention and Research Bangladesh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The arms will be labelled as group A and group B. The statisticians will be blind about the labelling. Thus, the masking will be ensured.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean and Chairman

Model Details: The intervention is based on Emotional Intelligence. A training session will be given in-person; a diary and a mobile app will be given to practice emotional intelligence at home.

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: December 12, 2023
• Study Start: January 27, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be made available after six months of the study completion and will be made accessible for up to 24 months.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

BA (1)